PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG2960BPXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032039564), received between Apr 3, 2019 and Apr 5, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K033394); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THERE WAS A PROBLEM WITH THE 29 X 60 X 135 PALMAZ GENESIS TRANSHEPATIC BILIARY STENT DELIVERY SYSTEM (SDS) ON A .035" OPTA PRO WHERE IT DISLODGES IN THE BODY BEFORE THE STENT WAS MEANT TO BE DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY. IT WAS MENTIONED THAT THE USER HAS HAD THREE DIFFERENT SIZES, ALL DISLODGED, AND THE STENT BEING KNOCKED OFF IN WRONG LOCATION. IT SEEMED THAT IF THE STENT MEETS ANY RESISTANCE, IT¿S KNOCKING IT OFF THE BALLOON, THEN WHEN THE PHYSICIAN GOES TO REMOVE THE STENT DELIVERY SYSTEM, THE STENT DISLODGES. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615878 ↗
• InjuryApr 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE STENT OF A 27MM PALMAZ LONG GENESIS ON .035¿ 29 X 60 X 135 OPTA PRO BALLOON EXPANDABLE STENT DELIVERY SYSTEM DISLODGED FROM THE DELIVERY SYSTEM BEFORE DEPLOYMENT. THEREFORE, A NEW NON-CORDIS STENT WAS PLACED CRUSHING THE DISLODGED STENT TO THE SIDE OF THE VESSEL. THE USER WAS TRAINED WITH THE DEVICE AND WAS OPENED IN A STERILE FIELD. THE ACCESS SITE WAS FEMORAL. THE LESION WAS MODERATELY CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 80%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). A 7F NON-CORDIS SHEATH WAS USED. A .035 GUIDEWIRE WAS USED. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE PRODUCT, OR ANY OF THE OTHER DEVICES USED WITH IT, HAD NOT BEEN RESTERILIZED. DURING PREP, THE STENT WAS NOT MANIPULATED. THE STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. PRIOR TO INSERTING THE SDS IN THE CATHETER, THE BALLOON WAS NOT INFLATED NOR PARTIALLY INFLATED. THE NEGATIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600881 ↗
• MalfunctionApr 3, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED, A STENT STRUT ON THE PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO WAS POKING OUT UPON REMOVAL FROM THE STERILE PACKAGING. NO PATIENT INJURY WAS REPORTED. THE INTENDED PROCEDURE WAS A COMMON ILIAC ARTERY STENTING. THE TARGET LESION LOCATION WAS THE RIGHT COMMON ILIAC ARTERY. THE DEVICE WAS STORED AS SPECIFIED BY THE INSTRUCTIONS FOR USE (IFU) AND NO ANOMALIES WERE NOTED TO THE PACKAGING BEFORE REMOVAL OF THE DEVICE. THE DEVICE WAS INSPECTED AND PREPPED AS SPECIFIED BY THE IFU. THE STENT WAS NOT MANIPULATED DURING PREP AS THE PREP WAS ABORTED UPON OBSERVATION THAT THE STENT STRUT WAS MALFORMED. ANOTHER UNKNOWN PRODUCT WAS UTILIZED, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478589 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033394. One submission often covers many models, so check the product and lot details in each record.

• Z-1363-2022 · May 20, 2022 · Open, Classified
  PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.